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NCT06449651From ClinicalTrials.govRecruiting

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies

  • Thrombocytopenia, Neonatal Alloimmune

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
39
Started
11 November 2024
Main results due
5 December 2029
Study sites
21
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 45 years.
  • Women only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization
* Has a history of greater than or equal to (\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (\<) 150×10\^9/Liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ICH) or severe hemorrhage based on a clinical review of the medical records
* Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood
* Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening
* For maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit

Exclusion Criteria:

* Currently pregnant with multiple gestations (twins or more)
* History of severe preeclampsia in a previous pregnancy
* History of myocardial infarction, unstable ischemic heart disease, or stroke
* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB))
* Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Study sites(21)

  • Universitair Ziekenhuis Leuven

    Leuven, Belgium

    Recruiting

  • Instituto de Medicina Integral Professor Fernando Figueira

    Recife, Brazil

    Completed

  • IDOR - Regional Rio de Janeiro

    Rio de Janeiro, Brazil

    Completed

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, Brazil

    Completed

  • CHRU Lille

    Lille, France

    Recruiting

  • Hopital trousseau- APHP

    Paris, France

    Recruiting

  • Semmelweis Egyetem

    Budapest, Hungary

    Recruiting

  • Sheba Medical Center

    Ramat Gan, Israel

    Completed

  • Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

    Milan, Italy

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Rome, Italy

    Recruiting

  • Haukeland University Hospital

    Bergen, Norway

    Recruiting

  • Oslo University Hospital HF Ulleval sykehus

    Oslo, Norway

    Recruiting

  • Universitetssykehuset Nord-Norge HF

    Tromsø, Norway

    Recruiting

  • St. Olavs Hospital

    Trondheim, Norway

    Recruiting

  • Univerzitna nemocnica L. Pasteura Kosice

    Košice, Slovakia

    Recruiting

  • Univerzitná nemocnica Martin

    Martin, Slovakia

    Recruiting

  • Fakultna nemocnica s poliklinikou Nove Zamky

    Nové Zámky, Slovakia

    Recruiting

  • Univerzitetni klinicni center Ljubljana

    Ljubljana, Slovenia

    Recruiting

  • Hosp. Virgen Del Rocio

    Seville, Spain

    Completed

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, Sweden

    Recruiting

  • Centre Hospitalier Universitaire Vaudois CHUV

    Lausanne, Switzerland

    Recruiting

Showing 21 of 21 sites. 16 of the 21 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06449651. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) | Trialion